At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,428 enrolled
Drug / intervention
HEPLISAV and/or Placebo +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
In Brief
A Phase 3 clinical trial evaluating HEPLISAV and/or Placebo and Engerix-B for Hepatitis B. Completed, enrolled 2,428 participants across 18 sites in 2 countries.
Detailed Summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesCanada, Germany
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedFeb 2007
Primary CompletionFeb 2008
Study CompletionMar 2008
TodayJul 2026
First PostedFeb 15, 2007
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.4 years ago
Interventions
HEPLISAV and/or Placebobiological
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
Engerix-Bbiological
Intramuscular (IM) injections on Week 0, Week 4, and Week 24